Yes, Livmarli (maralixibat) is FDA-approved for treating cholestatic pruritus in patients 3 months and older with Alagille syndrome.[1]
How does Livmarli work for Alagille syndrome?
Livmarli is an ileal bile acid transporter (IBAT) inhibitor that reduces bile acid buildup in the liver, easing intense itching (pruritus) caused by Alagille syndrome, a genetic disorder affecting bile ducts.[1][2] Approval came in 2021 based on the ICONIC trial, where 73% of patients saw major pruritus reductions.[2]
What about use in other conditions?
Livmarli is also approved for progressive familial intrahepatic cholestasis (PFIC) in patients 3 months and older, but Alagille remains its primary indication for this syndrome.[1] It's not approved for other liver conditions like primary biliary cholangitis.
Who makes Livmarli and what's the dosing?
Mirum Pharmaceuticals developed and markets it. Dosing starts at 190 micrograms per kg orally once daily, maxing at 380 mcg/kg, taken 30 minutes before breakfast using an oral solution.[1][2]
When does the patent expire?
Key U.S. patents on maralixibat for Alagille expire between 2031 and 2033, with pediatric exclusivity potentially extending to 2034. No generics are approved yet.[3]
Common side effects patients report
Diarrhea (35%), abdominal pain (30%), and vomiting affect many users, especially early on. Serious risks include liver issues or fat-soluble vitamin deficiencies; monitoring is required.[1][2]
[1]: FDA Label for Livmarli
[2]: Mirum Pharmaceuticals - Livmarli
[3]: DrugPatentWatch.com - Maralixibat Patents